Advaxis Receives Notice of Allowance From U.S. Patent and Trademark Office for Three Patent Applications With Multiple Claims Covering Its Cancer Immunotherapy Platform Technology

Published 7:30 AM ET Tue, 1 April 2014
Globe Newswire

PRINCETON, N.J., April 1, 2014 (GLOBE NEWSWIRE) -- Advaxis, Inc.(Nasdaq:ADXS), a biotechnology company developing the next generation of cancer immunotherapies, announced that the United States Patent and Trademark Office (USPTO) has issued a notice of allowance for three U.S. patent applications (12/213,696, 13/254,607, and 11/415,271) with claims of each application related to the Company's proprietary cancer immunotherapy platform technology. The patent with the latest date of expiry is 2030, without taking into account patent term extension.

The three patent applications allowed by the USPTO cover composition of matter and methods of use for combining the Advaxis proprietary immunogenic but non-toxic recombinant tLLO fused to full and partial antigens of particular interest in the treatment of multiple cancers, including B-cell lymphoma in both humans and animals. Additional patent applications also allowed by the USPTO encompass a method of use targeting multiple critical structural and identifying elements associated with B-cells and B-cell lymphomas and allow targeting of multiple structural peptides at the same time.

Also allowed separately are composition of matter and methods of use to accommodate the targeting of Advaxis treatments toward factors that are essential for tumors or metastases to form new blood vessels (angiogenesis) or that are expressed by tumor blood vessels. A method of use is allowed where multiple targets associated with angiogenesis can be targeted at the same time in animals as well as humans. These include, but are not limited to, HER2 and VEGFr2.

"These additional patents will allow us to expand the development of our immunotherapies to not only address existing tumors, but to also target factors expressed by tumors to establish blood vessels," commented Dr. Robert Petit, Chief Scientific Officer of Advaxis. "Our immunotherapy has already shown clinical activity in treating cervical cancer in women and bone cancer in pet dogs, and preclinical activity in multiple potential indications, including head and neck, anal, prostate, and breast cancers. These patents indicate growth of our ongoing program to further expand our intellectual property portfolio as we continue to develop Advaxis immunotherapies to treat multiple cancers."

"Following our recent patent issuance in Japan, the allowance of three patents in the United States supports our goal of developing and commercializing our immunotherapy treatments for multiple indications," commented Daniel J. O'Connor, Chief Executive Officer of Advaxis. "Patent protection of our proprietary immunotherapy platform has been a critical component of the recently executed deals in Asia, India, and for pet therapeutics globally and an achievement for our robust research team."

About Advaxis, Inc.

Advaxis is a clinical-stage biotechnology company developing the next generation of cancer immunotherapies. Advaxis's immunotherapies are based on a novel platform technology using live, attenuated bacteria to stimulate the immune system to selectively target cancer cells while reducing tumor defenses.

ADXS-HPV, Advaxis's lead immunotherapy for the treatment of HPV-associated cancers, has demonstrated improved survival and objective tumor responses in a Phase 2 trial in 110 patients with recurrent cervical cancer. Advaxis is now planning the registrational program for ADXS-HPV. ADXS-HPV is also being evaluated in other HPV-associated cancers including a Phase 2 in advanced cervical cancer, a Phase 1/2 in head and neck cancer, and a Phase 1/2 in anal cancer. ADXS-HPV has orphan drug status for both anal and head and neck cancers. As part of its global commercialization strategy to enter into regional licensing deals with other market dominant biopharmaceutical companies in territories where there is a high prevalence of HPV-associated cancers, Advaxis has granted exclusive licenses for the development and commercialization of ADXS-HPV in Asia and India.

ADXS-cHER2 is an immunotherapy for the treatment of HER2-overexpressing cancers (such as breast, gastric, esophageal, and other cancers in humans and for osteosarcoma in canines). Advaxis' lead animal-health immunotherapy, ADXS-cHER2, has demonstrated encouraging survival data in a trial in canine osteosarcoma. These data provide the rationale to advance this same immunotherapy into a Phase 1 clinical trial in patients with HER2-overexpressing cancers such as breast, gastric, esophageal, and others. The Company is preparing an IND submission for ADXS-cHER2 in the treatment of HER2 overexpressing cancers in humans in 2014 and has licensed ADXS-cHER2 for animal-health indications.

Advaxis has created more than 20 distinct immunotherapies based on its platform, either directly or through strategic collaborations with recognized cancer centers of excellence. We have clinical research collaborations with the University of Pennsylvania, Brown University, the Georgia Regents University Cancer Center, the Icahn School of Medicine at Mount Sinai, and others.

This news release contains forward-looking statements, including, but not limited to: statements regarding Advaxis's ability to develop the next generation of cancer immunotherapies; the safety and efficacy of Advaxis's proprietary immunotherapy, ADXS-HPV; whether Advaxis immunotherapies can redirect the powerful immune response all human beings have to the bacterium to cancers. These forward-looking statements are subject to a number of risks, including the risk factors set forth from time to time in Advaxis's SEC filings, including but not limited to its report on Form 10-K for the fiscal year ended October 31, 2013, which is available at http://www.sec.gov. Advaxis undertakes no obligation to publicly release the result of any revision to these forward-looking statements, which may be made to reflect the events or circumstances after the date hereof or to reflect the occurrence of unanticipated events, except as required by law. You are cautioned not to place undue reliance on any forward-looking statements.